# C_2012401EN.01000301.xml

| 28.12.2012 | EN | Official Journal of the European Union | C 401/3 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 1 )
)

2012/C 401/02

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------------------ |
| 12.11.2012 | Forxiga | dapagliflozin | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/12/795 | Film-coated tablet |
| Bristol Myers Squibb/AstraZeneca EEIG | | | | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | | | | |
| 15.11.2012 | Picato | ingenol mebutate | LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark | LEO Pharma A/S | Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/12/796 | Gel |
| LEO Pharma A/S | | | | | | | |
| Industriparken 55, DK-2750 Ballerup, Danmark | | | | | | | |
| 19.11.2012 | Capecitabine medac | capecitabine | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | EU/1/12/802 | Film-coated tablet |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | | | | |
| Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | | | | | | | |
| 19.11.2012 | Ibandronic acid Accord | Ibandronic acid | Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom | Accord Healthcare Limited | Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom | EU/1/12/798 | Concentrate for solution for infusion |
| Accord Healthcare Limited | | | | | | | |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom | | | | | | | |
| 19.11.2012 | Zoledronic acid Hospira | zoledronic acid | Hospira UK Ltd. Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Ltd. | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/12/800 | Concentrate for solution for infusion
Solution for infusion |
| Hospira UK Ltd. | | | | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | | | | |
| 22.11.2012 | Eylea | aflibercept | Bayer Pharma AG D - 13342 Berlin, Deutschland | Bayer Pharma AG | D - 13342 Berlin, Deutschland | EU/1/12/797 | Solution for injection |
| Bayer Pharma AG | | | | | | | |
| D - 13342 Berlin, Deutschland | | | | | | | |
| 22.11.2012 | Memantine Merz | Memantine | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland | EU/1/12/799 | Film-coated tablet
Oral solution |
| Merz Pharmaceuticals GmbH | | | | | | | |
| Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland | | | | | | | |
| 26.11.2012 | Constella | linaclotide | Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/12/801 | Capsule, hard |
| Almirall, S.A. | | | | | | | |
| Ronda General Mitre, 151, 08022 Barcelona, España | | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 8.11.2012 | Enyglid | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| KRKA, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 8.11.2012 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH Keltenring 1 + 3, Oberhaching 82041, Deutschland | 1 A Pharma GmbH | Keltenring 1 + 3, Oberhaching 82041, Deutschland |
| 1 A Pharma GmbH | | | | |
| Keltenring 1 + 3, Oberhaching 82041, Deutschland | | | | |
| 12.11.2012 | Ivemend | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 12.11.2012 | Olanzapine Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 15.11.2012 | Naglazyme | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | | | | |
| 15.11.2012 | Prolia | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 15.11.2012 | Retacrit | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
| Hospira UK Limited | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | |
| 15.11.2012 | Sutent | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 15.11.2012 | Xaluprine | Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | Nova Laboratories Limited | Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom |
| Nova Laboratories Limited | | | | |
| Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | | | | |
| 15.11.2012 | Xarelto | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 19.11.2012 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | | | | |
| 19.11.2012 | Actraphane | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, 53100 Siena, Italia |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina, 1, 53100 Siena, Italia | | | | |
| 19.11.2012 | Actrapid | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 19.11.2012 | Apidra | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, Deutschland |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, Deutschland | | | | |
| 19.11.2012 | Champix | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 19.11.2012 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/Pfizer EEIG | Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
| Bristol-Myers Squibb/Pfizer EEIG | | | | |
| Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | |
| 19.11.2012 | Incivo | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 19.11.2012 | Insulatard | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 19.11.2012 | Ketek | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, F-92160 Antony, France |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, F-92160 Antony, France | | | | |
| 19.11.2012 | Lumigan | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 19.11.2012 | Mirapexin | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 19.11.2012 | Mixtard | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 19.11.2012 | Mycophenolate mofetil Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 19.11.2012 | Myfenax | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 19.11.2012 | Protaphane | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 19.11.2012 | Revlimid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom | | | | |
| 19.11.2012 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 19.11.2012 | Simponi | Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland | Janssen Biologics B.V. | Einsteinweg 101, CB Leiden 2333, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, CB Leiden 2333, Nederland | | | | |
| 19.11.2012 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 19.11.2012 | Tysabri | Elan Pharma International Ltd. Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND | Elan Pharma International Ltd. | Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND |
| Elan Pharma International Ltd. | | | | |
| Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND | | | | |
| 22.11.2012 | Diacomit | Biocodex 7 avenue Gallieni, 94250 Gentilly, France | Biocodex | 7 avenue Gallieni, 94250 Gentilly, France |
| Biocodex | | | | |
| 7 avenue Gallieni, 94250 Gentilly, France | | | | |
| 22.11.2012 | GILENYA | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 22.11.2012 | Humira | AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd. | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd. | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 22.11.2012 | Olanzapine Apotex | Apotex Europe B.V. Darwinweg 20, 2333 CR Leiden, Nederland | Apotex Europe B.V. | Darwinweg 20, 2333 CR Leiden, Nederland |
| Apotex Europe B.V. | | | | |
| Darwinweg 20, 2333 CR Leiden, Nederland | | | | |
| 22.11.2012 | Prevenar 13 | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 22.11.2012 | Rasilez | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 22.11.2012 | Rasilez HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 22.11.2012 | Rasitrio | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | |
| 22.11.2012 | Remicade | Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, 2333 CB Leiden, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, 2333 CB Leiden, Nederland | | | | |
| 22.11.2012 | Riprazo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 22.11.2012 | Rivastigmine HEXAL | HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | HEXAL AG | Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
| HEXAL AG | | | | |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland | | | | |
| 22.11.2012 | RoActemra | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 22.11.2012 | Thyrogen | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 22.11.2012 | Tracleer | Actelion Registration Ltd Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
| Actelion Registration Ltd | | | | |
| Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | | | | |
| 22.11.2012 | Vimpat | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | | | | |
| 22.11.2012 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT United Kingdom | | | | |
| 26.11.2012 | Temodal | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom | | | | |
| 30.11.2012 | Gardasil | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, 69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, 69007 Lyon, France | | | | |
| 30.11.2012 | Olazax | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | | | | |
| 30.11.2012 | Silgard | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 30.11.2012 | Tygacil | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 30.11.2012 | Zevalin | Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | Spectrum Pharmaceuticals B.V. | Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |
| Spectrum Pharmaceuticals B.V. | | | | |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| -------------------------------------------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------- | -------------------------------------------------------------------------------------------------- |
| 8.11.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, Co. Galway, IRELAND |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, Co. Galway, IRELAND | | | | |
| 8.11.2012 | Meloxivet | Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | Eli Lilly and Company Limited | Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |
| Eli Lilly and Company Limited | | | | |
| Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | | | | |
| 12.11.2012 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, Co. Galway, IRELAND |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, Co. Galway, IRELAND | | | | |

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| ----------------------------- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

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( 1 )  OJ L 136, 30.4.2004, p. 1.

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